PMA supplement
P040044 S097: MYNX CONTROL™ Venous Vascular Closure Device (VCD) 6F-12F
FDA PMA supplement · Panel Track · Cordis US Corporation
Key facts
| Original PMA | P040044 |
|---|---|
| Supplement number | S097 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MYNX CONTROL™ Venous Vascular Closure Device (VCD) 6F-12F |
| Generic name | Device, hemostasis, vascular |
| Applicant | Cordis US Corporation |
| Product code | MGB |
| Received date | Nov 30, 2023 |
| Decision date | Jun 27, 2024 |
| Docket number | 24M-3091 |
| Notice date | Jul 8, 2024 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: